ARROW IPN038320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801902139204), received between Aug 20, 2021 and Oct 19, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K993933); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2021Contamination; Contamination

  THE COMPLAINT IS REPORTED AS: "DURING ONGOING CICA, PRESSURE INCREASED IN THE VENOUS LINE. THE DIALYSIS WAS STOPPED AS CICA WAS NO LONGER POSSIBLE. WHEN DISCONNECTING A TUBING-LIKE MATERIAL (APPROX. 10 CM LENGTH) WAS PULLED OUT OF THE LINE RUNNING TOWARDS THE PATIENT OF THE DIALYSIS CATHETER. THE MATERIAL DOES NOT SEEM LIKE COAGULUM BUT RATHER LIKE RUBBER; THE FOREIGN MATERIAL IS SECURED AND CAN BE EXAMINED." IT WAS REPORTED THE CUSTOMER DID NOT SEE THE PROBLEM WITH THE CATHETER, BUT WITH THE DIALYSIS MACHINE FROM FRESENIUS.

  Patient problems: Insufficient Information

  MAUDE report 12659786 ↗
• MalfunctionAug 20, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THE ARS SYRINGE WAS FOUND LEAKING DURING PATIENT PUNCTURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348602 ↗
• MalfunctionAug 20, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THE ARS SYRINGE WAS FOUND LEAKING DURING PATIENT PUNCTURE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348593 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993933. One submission often covers many models, so check the product and lot details in each record.

• Z-2373-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYS
• Z-1336-2018 · Dec 22, 2017 · Terminated
  ARROWg+ard Blue Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1
• Z-0658-2018 · Oct 17, 2017 · Terminated
  ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2
• Z-2334-2017 · May 9, 2017 · Terminated
  1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation
• Z-0639-04 · Feb 18, 2004 · Terminated
  Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions